Catheterization procedures are typically used when frequent or continuous injections of medications or fluids for nutritional support are provided to a patient. When a long treatment period is required (e.g., longer than 3 days) a long (6 cm or longer) and soft catheter is usually used, which allows maintaining it in the body of the treated subject up to several months.
For instance, in intravenous catheterization procedures a single puncture of a blood vessel is made for inserting and advancing the catheter device towards a selected location in a vessel wherein it is left for periodic use. In this way repetitive piercing of patient's vessels is avoided. Intravenous catheter insertion devices are typically designed to allow inserting the catheter while preserving a sterile environment and preventing the passage of blood out via the catheter insertion apparatus.
The insertion of many intravenous catheters is carried out by placing an introducer catheter comprising an introducer needle for making the puncture (over-the-needle). After the introducer catheter is placed in the target vessel the introducer needle is withdrawn therefrom and the catheter tube may be then inserted therethrough into the selected vascular location.
In some catheterization procedures a removable introducer, such as the peelable introducer (e.g., Peel-Away®), is used in the insertion step. For example, the Peel-Away® introducer consists of a disposable sheath needle having two opposing tearing tabs attached to its proximal end (i.e., trailing end). The insertion of the Peel-Away® introducer into the vessel is done in much the same way as the over-the-needle procedure i.e., first the blood vessel is punctured by the introducer needle contained within the needle sheath and thereafter the introducer unit is advanced into the vessel, the introducer needle is then removed, and the catheter tube is inserted into the selected vascular location. The catheter insertion step is usually carried out by pushing the catheter tube manually via an entry port of the introducer.
After the catheter tube is placed in the vessel the needle sheath is removed, by retracting it from the patient's vessel and peeling it off the catheter by grasping its tearing tabs and pulling them laterally in opposite directions, thereby tearing the needle sheath apart along its longitudinal length.
The relatively long periods of time during which the catheter remains in its position in the patient's vein may cause catheter related infections. These infections are typically caused by chemical irritation, contamination of the catheter during its insertion, or by organisms dwelling on the skin of the patient that enter the punctured vein through the outer surface of the catheter due to catheter movement in or out of the insertion site.
An intravenous catheter assembly is described in WO 03/084428 wherein a sterile catheter insertion apparatus comprised of an integral sterile sheath comprising the catheter tube therein is used. Various catheter insertion apparatuses are also described in WO 06/085331, the disclosure of which is incorporated herein by reference, wherein the catheter tube contained in a flexible sleeve is inserted into the patient's vessel by utilizing catheter advancing means. However, the above mentioned catheter insertion apparatuses are designed for insertion using the conventional over-the-needle technique wherein the catheter introducer remains in the punctured vessel during the entire procedure.
Catheter insertion procedures in which a peelable introducer is utilized for introducing the catheter tube into the body of the treated subject involves proximal and distal movement of the catheter tube, particularly after completing the insertion of the catheter tube and retracting the peelable introducer proximally for removing it from the vessel and splitting it. Undesirably, during these steps a potion of the catheter tube is left out of the patient's body which requires either introducing said portion through the skin without the introducer, or leaving it exposed on the skin susceptible for kinking and snagging. Additionally, catheter insertion devices utilizing peelable introducers, and procedures employing said devices, do not provide means for securing the peelable sheath of said peelable introducer and for securely splitting said sheath during its retraction from the patient's body.
The catheter insertion procedures of the prior art have not yet provided satisfactory solutions for inserting a catheter tube into the body of the treated subject using a catheter introducer while maintaining sterile surroundings, and for preventing the displacement and contamination of the catheter tube near the site of insertion into the body of the treated subject.
It is therefore an object of the present invention to provide a method and apparatus for inserting a catheter tube into the body of a treated subject by means of a catheter introducer while maintaining the catheter tube within sterile surroundings.
It is another object of the present invention to provide a method and apparatus for inserting a catheter tube into the body of a treated subject by means of a catheter introducer while maintaining sterile surrounding about the insertion site.
It is a further object of the present invention to provide simplified method and apparatus for securely inserting a catheter tube into the body of a treated subject by means of a catheter introducer, wherein the catheter tube is kept in a removable sterile environment maintaining means.
It is yet another object of the present invention to provide simplified method and apparatus for placing a catheter tube by means of a peelable introducer, for removing said peelable introducer and maintaining said catheter tube in place while preventing the kinking of the catheter tube near the insertion site
It is yet a further object of the present invention to provide simplified method and apparatus for placing a catheter tube by means of a peelable introducer, wherein the catheter tube is protected from direct contact throughout the treatment process, and wherein portions of the catheter tube may remain untouchably outside the body of the treated subject.
It is yet a further object of the present invention to provide simplified method and apparatus for placing a catheter tube by means of a standard catheter introducer device, wherein the catheter tube is protected from direct contact throughout the treatment process, and wherein portions of the catheter tube may remain untouchably outside the body of the treated subject.
An additional object of the present invention is to provide a device for placing a catheter tube by means of a peelable introducer, and for maintaining said catheter tube in place during the provision of medication.
Other objects and advantages of the invention will become apparent as the description proceeds.